It has long been recognized that there are many patients in hospitals, nursing homes, and other such institutions, as well as invalided, deformed or crippled persons who are not toilet-trained or whose bowel movements, defecation and/or urinary functions are involuntary and uncontrolled so that their waste products cannot be contained or retained. Futhermore, there are many patients who have, as a result of various diseases, required the performance of an ostomy, whereby an exit for the feces is created before it reaches the rectum. This exit, known as a stoma, therefore requires a collecting device for use to collect feces exiting therefrom.
In addition, there are many female patients who have suffered various bladder infections, who have required the insertion of various tubes and other such means for collecting urine directly from their bladders. There are also many male patients who are physically disabled to the point where they are unable to leave their beds in order to urinate. In each of these cases, these unfortunate conditions exist for a variety of known reasons, and each is not only of great inconvenience to the patient or persons who suffer from them, but additionally present many problems such as unpleasant odors, unsanitory conditions, increased nursing care, and generally extreme discomfort to the patient.
Various devices have been developed in each of these situations in order to act as collecting devices for the excretions connected with each of the body openings discussed above. Thus, in the case of a fecal bag, U.S. Pat. No. 3,548,828 reveals a collecting appliance used in paraplegic and other bowel incontinent persons. This device, besides being impossible to produce commercially, suffers from many other serious shortcomings. Thus, the device of U.S. Pat. No. 3,548,828 cannot be inserted into the anus without causing extreme irritation to the patient, particularly since it does not present a smooth and regular surface to the body opening. In addition, this device suffers from other serious defects, such as leakage, etc. since it does not provide a smooth and/or continuous surface between the anchoring means 6 and the collecting bag 38. As can be seen clearly in FIGS. 3 and 4 of this patent, this device also requires that the patient have functioning sphincter muscles, and is adapted to contain an inflatable and deflatable adaptor means 12, quite apart from its anchoring means 6, which is inflated only during use, when the bag 38 is attached thereto, and which is deflated and closed by the functioning rectal sphincter muscles when the bag is removed and cap 36 is attached thereto. These difficulties which prevent the utilization of this device for patients who have completely lost control of these muscles, in addition to the extreme irritation caused by the neither smooth nor continuous outer surfaces of this device, particularly in view of tubes 22 and 19 which are used for inflation of its two inflatable portions, have rendered such devices totally useless.
Furthermore, the construction of these prior art devices have required the application of various adhesives in order to complete same, and the use of such materials in connection with such devices for insertion into the human body has been strictly forbidden by the Food and Drug Administration.
As for those patients who have had colostomies and require collection of fecal matter from a stoma, in the past this has been done by the adhesive attachment of various bags to the external surface of the stoma. These devices have therefore also resulted in serious consequences, including irritation and ulceration of the skin surface.
In connection with the collection of urine directly from a female bladder, this has, in the past, required the insertion of various devices directly into the bladder, and this has caused serious bladder infections. Specifically, the most commonly employed prior art device has included inflatable means for insertion directly into the bladder, and tubular means for removing urine therefrom. Again, insertion of any foreign matter into the bladder itself has consistently resulted in serious bladder infections. Similar problems have been encountered with respect to the collection of urine from bed-ridden male patients.
In connection with the application of enemas, such as barium enemas, this has in the past been extremely difficult, particularly with incontinent patients who cannot control or prevent the release of barium material prematurely.
Therefore, in each of these cases, there has been an extreme and urgent need for the development of a collecting device which overcomes these difficulties.
It is therefore an object of the present invention to provide a collecting bag which overcomes these and other problems associated with each of these prior art devices.
It is yet another object of the present invention to provide such a collecting device which is both sanitary and easily disposable, and which is relatively simple to use and sufficiently cheap to manufacture in order to meet the single use, throw-away concept of modern day medicine.
It is yet another object of the present invention to provide a collecting device which may be used continuously, and for long periods of time, without irritation to the body opening.
It is yet another object of the present invention to provide a collecting bag which can be easily replaced by relatively untrained individuals, without pain or other such difficulties to the patient, and which can be periodically inserted and removed without causing undue irritation or infection.
It is yet another object of the present invention to provide a collecting device which may be inserted into a stoma and employed by ostomy patients, with all of the above-noted advantages.
It is yet another object of the present invention to provide a collecting bag which may be employed by females for insertion into the urethra for collection of urine therefrom.
It is yet another object of the present invention to provide a collecting bag which may be reasonably employed for the collection of urine from bedridden male patients.
It is yet another object of the present invention to provide a collecting bag which helps eliminate odors and other such difficulties resulting from leakage associated with the involuntary and uncontrolled expelling of feces by such patients.
It is yet another object of the present invention to provide a collecting device which eliminates the transmission of bacteria and bacterial infections, and which can be used in connection with the analysis of excretions from various body openings.
It is yet another object of the present invention to provide a collecting bag which may be used as a fecal bag even where the defecation function of the rectal or sphincter muscles has been completely lost due to local disease, local inflammatory disease as in the case of typhoid, cholera, cholera or dysentery, central nervous system defects or disorders, or other reasons whereby there is still sufficient rigidity in the wall of the rectal ampulla to offer support for any structure inserted for engagement therewith.
It is yet another object of the present invention to provide a collecting device which may also be adapted to be used for the provision of an enema, such as barium enema, again with all of the above-noted advantages.
It is yet another object of the present invention to provide a method for manufacturing each of the above-noted collecting bags.